Pacira Announces New Data Supporting Clinical and Pharmacoeconomic Utility of EXPAREL in Patients Undergoing Various Surgical Procedures
Pacira Pharmaceuticals Inc. (NASDAQ:PCRX) today announced data from three studies evaluating the clinical and pharmacoeconomic utility of EXPAREL(R) (bupivacaine liposome injectable suspension) for postsurgical pain control in patients undergoing colorectal surgery, breast reconstruction and total knee replacement surgery. The data were presented this month at the annual meetings of the World Congress of Enhanced Recovery after Surgery and Perioperative Medicine, Plastic Surgery Research Council (PSRC) and International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
The data presentation details and key findings are summarized below:
May 10, 2015 at 9:50 a.m. EST
Liposomal Bupivacaine Improves Outcomes in Ileostomy Reversal Surgery and May Be Effective in More Complex Enhanced Recovery Procedures
World Congress of Enhanced Recovery after Surgery and Perioperative Medicine
Lead Author: Aaron Skolnick; Duke University Health System, Durham, NC
- Forty-three patients undergoing loop ileostomy closure who received EXPAREL via subcutaneous and suprafascial infiltration had lower opioid consumption, pain scores, costs and shorter lengths of hospital stay compared to thirty-five patients who received bupivacaine HCl for postsurgical analgesia. Researchers hypothesize that EXPAREL may demonstrate similar outcomes in more complex surgeries if added to an enhanced recovery program. Read the full abstract here: http://link.springer.com/article/10.1007/s12630-015-0372-5
May 15, 2015 at 2:03 p.m. PT
Comparative Study of Liposomal Bupivacaine versus Paravertebral Block for Pain Control Following Mastectomy with Immediate Tissue Expander Reconstruction
PSRC 60th Annual Meeting in Seattle, WA
Lead Author: Jad M. Abdelsattar, MBBS; Mayo Clinic, Rochester, MN
- Patients who received local infiltration with EXPAREL (n=53) versus preoperative paravertebral block (n=44) for pain control following mastectomy with immediate tissue expander breast reconstruction reported lower pain scores, and required less opioids and antiemetic medication for nausea. Read the full abstract here: http://ps-rc.org/meeting/abstracts/2015/68.cgi
May 19, 2015 at 8:30 a.m. ET
Evaluating Clinical and Economic Outcomes Associated with Liposomal Bupivacaine for Postsurgical Pain Following Total Knee Arthroplasty
ISPOR 20th Annual Meeting in Philadelphia, PA
Lead Authors: Carl Asche, Ph.D., and Carmen Kirkness, Ph.D,; Center for Outcomes Research, University of Illinois College of Medicine, Peoria, IL
- More patients who received EXPAREL infiltration (n=134) compared to continuous nerve blocks via elastomeric pump (n=134) following knee replacement surgery were able to ambulate on the day of surgery and were discharged from the hospital in 3 days or less. Read the full abstract here: http://www.ispor.org/RESEARCH_STUDY_DIGEST/details.asp
“This collection of data reinforces the positive impact that EXPAREL infiltration can make on both the patient recovery experience and hospital economics,” said Dave Stack, president, chief executive officer and chairman of Pacira. “These studies add to the growing body of evidence demonstrating the value of EXPAREL as part of a multimodal pain management approach aimed at opioid minimization and enhancing patient care.”
EXPAREL is indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam(R), a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain score with up to a 45 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence greater-than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting.
Please see the full Prescribing Information for more details available at http://www.exparel.com/pdf/EXPAREL_Prescribing_Information.pdf.
Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s flagship product, EXPAREL(R) (bupivacaine liposome injectable suspension), indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia, was commercially launched in the United States in April 2012. EXPAREL and two other products have successfully utilized DepoFoam(R), a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.
Forward Looking Statements
Any statements in this press release about our future expectations, plans, outlook and prospects, including statements about expected non-GAAP product gross margins and operating expenses, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our plans to expand the use of EXPAREL to additional indications, including nerve block, oral surgery and chronic pain, as well as pediatrics; the related timing and success of a United States Food and Drug Administration supplemental New Drug Application; our receipt of FDA approval of our nerve block indication; the adverse effects and impacts of FDA warning letters; the outcome of the U.S. Department of Justice inquiry; our plans to evaluate, develop and pursue additional DepoFoam-based product candidates; clinical studies in support of an existing or potential DepoFoam-based product; our plans to continue to manufacture and provide support services for our commercial partners who have licensed DepoCyt(e); our commercialization and marketing capabilities; our and Patheon UK Limited’s ability to successfully and timely construct dedicated EXPAREL manufacturing suites; and other factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2014, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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